Pilot for the Analysis of Usability in the Use of the Diacare Platform for People With Type 2 DM and Their Professionals

January 27, 2021 updated by: Rosa Mª Flores, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Diacare Project: Pilot for the Analysis of Usability in the Use of the Diacare Project for People With DM2 and Their Professionals

The objective of this study is to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment.

Study Overview

Status

Completed

Conditions

Detailed Description

Type 2 diabetes mellitus is a chronic disease that increases the risk of patients suffering from heart disease, embolisms and microvascular complications such as blindness, kidney failure and peripheral neuropathies. In order to achieve an optimum level of independence in their self care, it is essential that type 2 DM patients take responsibility for the situation and be actively involved in the control of their health. Technology can solve some of the current challenges of chronic diseases such as type 2 DM, and in fact there are studies that suggest that chronic diseases can be more manageable with the support of mHealth. In this context, the Diacare platform has been designed with the idea of improving the self-management and self-care of patients with type 2 DM in a more personalized and individual way. The Diacare platform consists of an application, a fitbit wristband for activity monitoring and a web platform for professionals. This research project wants to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment. For this, a total of 35 patients and their respective health professionals will be recruited for the study and will use the DIACARE platform for 3 months. The results of this pilot will be collected through qualitative and quantitative data through the DIACARE platform and from questionnaires that will be administered to patients and professionals and will allow the evaluation of the technology developed.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • CAP Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The selected participants will belong to a primary care center based at Hospitalet de Llobregat, Barcelona (Spain).

Description

Inclusion Criteria:

  • People diagnosed with type 2 DM based on clinical criteria
  • People who own a Smartphone and have competences in the use of technology

Exclusion Criteria:

  • People that cannot go to the primary care center
  • People with cognitive deterioration
  • People with limitations in the practice of physical exercise
  • People with a life expectancy lower than 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the Diacare platform
Time Frame: 3 months
System Usability Scale (SUS) is a self-administered questionnaire to evaluate the usability of the developed tool.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Fundació TicSalut

Investigators

  • Principal Investigator: Rosa Flores, MD, Institut Català de la Salut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2020

Primary Completion (Actual)

July 24, 2020

Study Completion (Actual)

July 24, 2020

Study Registration Dates

First Submitted

January 21, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIACARE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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